# FDA 483 - Choksi Laboratories Limited - September 06, 2019

Source: https://www.globalkeysolutions.net/records/483/choksi-laboratories-limited/a7901596-1627-4dec-af3c-10538d725cc2

> FDA 483 for Choksi Laboratories Limited on September 06, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Choksi Laboratories Limited
- Inspection Date: 2019-09-06
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Choksi Laboratories Limited, a control testing laboratory in Indore, India, received a Form 483 for significant data integrity issues and a pervasive lack of quality unit oversight. The inspection revealed fabricated documents, backdated records, incorrect test results, and a failure to investigate out-of-specification results and unknown impurities. These serious deficiencies indicate a systemic breakdown in cGMP compliance and data reliability.

## Related Documents

- [483 - 2016-06-01](https://www.globalkeysolutions.net/records/483/choksi-laboratories-limited/b93da304-bd64-4971-b9c1-b719c54b43db)
- [483 - 2018-04-25](https://www.globalkeysolutions.net/records/483/choksi-laboratories-limited/8d15e946-1b95-4570-9dd7-0b39fb7260f3)

## Related Officers

- [Pritik J Upadhyay](https://www.globalkeysolutions.net/people/pritik-j-upadhyay/658629d4-ea34-4da4-9a64-2898b4ec71f6)
- [Arsen Karapetyan](https://www.globalkeysolutions.net/people/arsen-karapetyan/4000d909-277b-4533-992f-4e3627c8ce40)

Company: https://www.globalkeysolutions.net/companies/choksi-laboratories-limited/9dd2f413-47cd-4d9e-916a-96a24127522c

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1